MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Purulent Discharge (1812); Headache (1880); Hematoma (1884); Unspecified Infection (1930); Vomiting (2144); Malaise (2359); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 02/10/2023

Event Type  Injury  

Event Description

Information was received from a patient representative, patient, and healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system for non-malignant pain.Per the patient representative, the pump was used to deliver unknown baclofen and an unknown drug.This reporter was unable to recall one of the pump medications, but it was something similar to morphine.Dose and concentration information was not reported.Per the rep, the pump was used to deliver unknown morphine at a concentration of "4.0" at 0.5mg/day.On (b)(6) 2023, it was reported that the patient went to the emergency room because they had an allergic reaction to an adhesive.During a call to technical services on this date, the patient was too sick to speak on the phone.On (b)(6) 2023, it was reported that, post-pump replacement, "the patient may be infected".The patient was being treated with antibiotics.In regards to environmental, external, or patient factors that may have led or contributed to the issue, the patient reported that they may have been allergic to surgical tape and/or glue.Diagnostics/troubleshooting performed was not applicable.As of (b)(6) 2023, the issue was not resolved.Surgical intervention had not occurred and it was unknown if surgical intervention was planned.The patient's weight and medical history was asked but was unknown.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that to the reporter's knowledge no surgical date was currently scheduled.It was unknown the results of any diagnostics or troubleshooting related to the post operative infection.The actions and interventions taken to resolve the issue was the patient was prescribed antibiotics.It was unknown if the post operative infection resolved.Per a patient¿s representative report on 2023-02-24, the pump also contained baclofen and morphine 4mg/ml.

Manufacturer Narrative

Continuation of d10: product id 8780; serial# (b)(6); implanted: (b)(6) 2023; product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780; serial# (b)(6); ubd 2025-01-20; udi# (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer who reported their healthcare provider shut off the pump and the patient went through withdrawals.The patient went to (clinic) and was puking, had headaches, and was laying over in a chair.The patient stated that was a couple days after they got out of the hospital, date unknown.The patient stated it should have been in their patient chart that the patient cannot have glue as they have bad reactions.The patient stated they did the recent pump surgery and did staples and put glue and after 3rd day right before the withdrawals, all of a sudden stomach burned and itched and the patient was told to not take bandage off.The patient stated they went to er (emergency room) and they removed the bandage and it was all full of pus and everything.The patient stated the glue caused this and they couldn't remove staples which caused an infection.The patient was put back in hospital as they were worried would go into pump and around spinal cord.The patient stated while in hospital their back swelled like 2 kiwis and didn't know why so they drained it and turned out to be csf (cerebral spinal fluid) fluid.They expected it to go away which did not and they drained again but it had blood and came back again and was told had to heal on own.Per the patient 3/4 gone now and this all began first week of surgery of newest pump.The pump was used to deliver dilaudid at 1.3619mg/day and baclofen 110.65mcg/day.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16482055
• MDR Text Key: 310673435
• Report Number: 3004209178-2023-02989
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• UDI-Public: 00763000634100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2023
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female